An 8-Week Randomized, Controlled, Examiner-Blind, Clinical Study Investigating the Efficacy of an Experimental Dentifrice Containing Stannous Fluoride in Improving Gingival Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- HALEON
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Change from Baseline in Overall Modified Gingival Index (MGI) at Week 8
研究概览
简要总结
The aim of this study will be to evaluate the ability of using an experimental dentifrice containing 0.454 percent (%) weight for weight (w/w) Stannous Fluoride (SnF2) to reduce gingivitis and plaque accumulation, compared with a regular fluoride toothpaste (negative control) in participants with mild to moderate gingivitis.
详细描述
This will be a single-center, 8-week randomized, controlled, single blind (examiner only), 2-treatment arm, parallel group, stratified study, to evaluate the efficacy of using an experimental dentifrice containing 0.454% w/w Stannous Fluoride, twice daily in reducing gingivitis and plaque accumulation in a population with a clinically measurable level of gingivitis. The clinical efficacy of the experimental dentifrice will be compared to a commercially available regular fluoride dentifrice as negative control. Sufficient participants will be screened to randomize approximately 110 participants (approximately 55 per group) to ensure approximately 100 evaluable participants (approximately 50 per group) complete the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant provision of a signed and dated informed consent document indicating that the participant will have been informed of all pertinent aspects of the study before any assessment is performed.
- •A participant who is willing and able to comply with scheduled visits, treatment plan and other study procedures, study restrictions, Lifestyle considerations.
- •A participant in good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the participant's ability to understand and follow study procedures and requirements.
排除标准
- •A participant who is an employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family.
- •A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation.
- •A participant with, in the opinion of the investigator or medically qualified designee, an acute or chronic medical, psychiatric condition or laboratory abnormality or any other clinical serious or unstable conditions (Example(e.g.), cardiovascular diseases, diabetes, liver disorders, and kidney disorders) that may increase the risk associated with study participation or investigational product administration, or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study.
- •A participant who is a pregnant female (self-reported) or intending to become pregnant over the duration of the study.
- •A female participant who is breastfeeding.
- •A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
- •A participant unwilling or unable to comply with the lifestyle considerations described in this protocol.
- •A participant who is a current smoker or an ex-smoker (including vaping) who stopped within 6 months of Screening.
- •A participant who is using smokeless forms of tobacco (example, chewing tobacco, gutkha, paan containing tobacco, nicotine-based e-cigarettes).
- •A participant who has diagnosed xerostomia or is taking any medication that in the view of the investigator, is causing xerostomia.
- •A participant who has a medical condition which could directly influenced gingival bleeding (e.g., type 2 diabetes).
- •A participant who has a bleeding disorder that could affected study outcomes and/or participant safety.
- •A participant who has a recent history (within the last year) of alcohol or other substance abuse.
- •A participant who has a severe oral condition (e.g., acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant/examiner if they participate in the study.
- •Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush.
- •A participant currently taking any such medication or oral care product which in opinion of the investigator could affect gingival condition.
- •Dental exclusions:
- •A participant who has active caries that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.
- •A participant who has dentures (partial or full).
- •A participant who has fixed orthodontic appliances or is undergoing active or recent (within 3 months of Screening) orthodontic treatment, which, in the opinion of the investigator, could interfere with study procedures, assessments or outcomes.
- •A participant who has other orthodontic devices (e.g., bands, fixed retainers, or removable retainers) that could, in the opinion of the investigator, interferes with study procedures, assessment, or outcomes.
- •A participant who has numerous restorations in a poor state of repair.
- •A participant who has any dental condition (e.g., overcrowding) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study.
- •A participant who has had dental prophylaxis and teeth bleaching within 12 weeks of Screening.
- •A participant who has high levels of extrinsic stain or calculus deposits, in the opinion of the investigator, that could interfered with plaque assessments.
- •A participant who has previously been enrolled in this study.
- •A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
研究组 & 干预措施
Test Dentifrice
Participants will brush their teeth thoroughly for at least one timed minute twice daily (morning and evening) for 8 Weeks, using a full ribbon of Test Dentifrice on the head of the toothbrush provided.
干预措施: Test Dentifrice (Drug)
Reference Dentifrice
Participants will brush their teeth thoroughly for at least one timed minute twice daily (morning and evening) for 8 Weeks, using a full ribbon of Reference Dentifrice on the head of the toothbrush provided.
干预措施: Reference Dentifrice (Colgate Cavity Protection Dentifrice) (Drug)
结局指标
主要结局
Change from Baseline in Overall Modified Gingival Index (MGI) at Week 8
时间窗: Baseline and Week 8
The MGI assessment is a non-invasive visual evaluation to assess the symptoms of gingivitis. It will be assessed on all scorable teeth. For each tooth, 3 scores will be recorded and will be scored on a 5-point scale ranging from 0 to 4, where 0 equals (=) Absence of inflammation, 1= Mild inflammation; slight or little change in color; little change in texture of any portion of the marginal/ papillary gingival unit, 2= Mild inflammation; criteria as above, but involving the entire marginal/ papillary gingival unit, 3= Moderate inflammation; glazing, redness, edema, and/ or hypertrophy of the marginal/ papillary gingival unit, 4= Severe inflammation; marked redness, edema and/ or hypertrophy of the marginal/ papillary gingival unit, spontaneous bleeding, congestion, or ulceration. Change from Baseline= Week 8 score minus Baseline score. Lower scores indicate symptom improvement.
次要结局
- Change from Baseline in Interproximal MGI at Week 8(Baseline and Week 8)
- Change from Baseline in Overall Turesky Modification of the Quigley Hein Plaque Index (TPI) at Week 8(Baseline and Week 8)
- Change from Baseline in Interproximal TPI at Week 8(Baseline and Week 8)